BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1906530 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06162
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER(S) H10H24027 AND H10G24011 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CONDENSATION FOUND IN A SINGLE PACKAGE OF GENIE CLOSED VIAL ACCESS DEVICE -CLAVE- WITH LOT # 1983882. PRODUCT IS FROM ICU MEDICAL INC. (B)(4) WAS CONTACTED BY PHONE AND THIS SINGLE PACKAGE WAS HANDED TO HIM THIS AFTERNOON FOR HIM TO REPORT THE ISSUE TO HIS COMPANY.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT IN (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES WERE ONGOING. IN (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING FROM THE EVENT OF PERITONITIS. A CAUSALITY STATEMENT FOR THE EVENT OF PERITONITIS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization